CI

At a glance

ClinicalIndex Comparison Record
N/ARecruiting· 40 target
Drug / intervention
Stimit Activator 1device
Likely dose
Not stated in record
Key inclusion· 4
  • ✓Age 21 years or older
  • ✓Recently placed on invasive mechanical ventilation, enrolled as soon as possible after intubation
  • ✓No more than 7 days of mechanical ventilation at enrollment
  • ✓Predicted to remain on mechanical ventilation for 48 hours or longer post-randomization
Key exclusion· 14
  • ✕Actively treated with continuous infusion of neuromuscular blocking agents beyond the enrollment period
  • ✕Medical condition known to affect the phrenic nerve or respiratory muscles
  • ✕Any patients with ICP probe
  • ✕Metallic device implants or body penetrating metallic devices in upper body within 30cm from the coils; known anatomy or devices in neck area that would interfere with headset placement

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05883163
NCT05883163N/ARecruitingMonitorUpdated 7mo ago · Completion was 3mo ago
Slow Enrollment
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STIMIT Activator 1 Pivotal Study

Stimit AG·interventional·Posted May 31, 2023·Updated Nov 14, 2025

In Brief

A clinical study evaluating Stimit Activator 1 for Diaphragm Issues. Currently recruiting, targeting 40 participants across 4 sites in 2 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

The study is a prospective, multi-center, randomized, controlled study using adaptive design to assess the evidence of safety and performance of the STIMIT Activator 1 System in the treatment of patients who have been mechanically ventilated for up to 7 days and are predicted to require additional minimum 48 hours of mechanical ventilation or longer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiaphragm Issues
CountriesCanada, United States
Collaborators--

Timeline

N/ARecruitingOverdue
202420252026
First PostedMay 31, 2023
Enrollment StartJan 24, 2024
Primary CompletionApr 1, 2026
Study CompletionJul 1, 2026
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 3.1 years ago

Interventions

Stimit Activator 1device

The Stimit Activator 1 System will be used to stimulate the phrenic nerve resulting in diaphragm activation.